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Correlation Between the Interstitial and Arterial Glucose in Post Surgery Patients

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00733148
First received: August 7, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients) aims to develop a low-risk monitoring and control device which allows maintaining metabolic control in intensive care units. A system will be developed comprising three subsystems: a body interface for the delivery of biofluids, biosensors for the determination of glucose concentration in these biofluids and an adaptive control algorithm that generates advice and thus represents a decision support system with respect to insulin infusion rate to establish glycaemic control in critically ill patients. Within a closed loop system, intensified insulin treatment will make use of the calculations leading to external regulation of glucose.

It is the aim of this study to evaluate the correlation between arterial blood glucose concentrations and interstitial fluid glucose concentrations in post surgery patients in the Intensive Care Unit (ICU). Interstitial fluid glucose concentrations are based on microdialysis in subcutaneous adipose tissue and calculated using the ionic reference technique.


Condition Intervention
Intensive Care
 Drug: dosing of insulin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Randomised Trial to Investigate the Correlation Between the Interstitial and Arterial Blood Concentrations of Glucose During Subcutaneous Microdialysis Glucose Monitoring in Post Surgery Patients at the Intensive Care Unit.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Time concentration profiles of arterial blood glucose concentrations and interstitial fluid glucose concentrations [ Time Frame: hourly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prospectively calibrated interstitial fluid glucose concentration profiles [ Time Frame: hourly ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2004
Study Completion Date: April 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Routine Care
 Drug: dosing of insulin
Dosing od insulin is calculated by a computer based algorithm
Other Name: Model predictive control
2
Insulin infusion based on model predictive algorithm (MPC)
 Drug: dosing of insulin
Dosing od insulin is calculated by a computer based algorithm
Other Name: Model predictive control

Detailed Description:

This trial includes a screening visit (V1) and a monitoring visit (V2) and follow-up assessment. Visit 1 will be performed before performance of surgery to obtain informed consent and to assess patient eligibility. At Visit 2 monitoring visit after surgery) arterial blood glucose values will be monitored and subcutaneous sampling of ISF with microdialysis for glucose determination will be performed. Visit 2 will last from admittance to the ICU for 48 hours. In a follow-up assessment, two weeks after the end of visit 2, further clinical relevant data for the two week period after visit 2 will be collected.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with a blood glucose level of more than 120 mg/dl (6.7mM) at admission to the ICU after surgery

Criteria

Inclusion Criteria:

  • Signed informed consent obtained before any trial-related activities.
  • Planned surgery and post-surgery stay in the ICU.
  • Study day inclusion criteria: Increased blood glucose levels at admission to the ICU ( > 120 mg/dL; > 6.7 mM)
  • Age of patients in the range from 18 to 90 years.

Exclusion Criteria:

  • Known or suspected allergy against insulins.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
  • Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733148

Locations
Austria
Medical University Graz
Graz, Styria, Austria, A8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R. Pieber, MD Medical University of Graz
  More Information

Additional Information:
background information about the overall project  This link exits the ClinicalTrials.gov site

No publications provided by Medical University of Graz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas R. Pieber, Medical University of Graz
ClinicalTrials.gov Identifier: NCT00733148     History of Changes
Other Study ID Numbers: CM1
Study First Received: August 7, 2008
Last Updated: August 7, 2008
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
glucose, interstitial, intensive care

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013